Razavi Journal of Medicine

Razavi Journal of Medicine

The effect of Rosa Canina hydroalcoholic extract on ventricular arrhythmias in heart failure patients with implantable cardioverter-defibrillators: A Randomized Clinical Trial

Document Type : Original Article

Authors
1 Department of Cardiovascular Diseases, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
2 Patient Safety Research Center, Clinical Research Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
3 Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Abstract
Background: Heart failure (HF) transpires when the heart is unable to pump sufficient blood. A key cause of ventricular arrhythmias in HF is oxidative stress and prolonged inflammation. Few clinical studies exist on the heart-related effects of Rosa Canina, especially in high-risk patients with implantable cardioverter-defibrillators (ICDs).

Objectives: This study was designed to assess whether Rosa Canina extract could reduce ventricular arrhythmias in these patients.

Methods: This double-blind, randomized clinical trial was conducted on 100 patients with HF and ICDs. Patients were randomly assigned to two groups: one received Rosa Canina extract tablets (250 mg, two tablets twice daily) and the other received placebo tablets of similar shape and color (two tablets twice daily). The extract was prepared and standardized in the pharmacognosy laboratory using the wet granulation method. Patients were followed for one month, and the number of ventricular arrhythmias, PVCs, ICD shocks, and hospital admissions was recorded.

Results: The Rosa Canina group had significantly lower PVC frequency (22% vs. 58%; P<0.001) and lower ICD shock frequency (14% vs. 40%; P=0.003) compared to the placebo group. In contrast, hospitalization rates did not differ significantly between groups (P = 0.180). Furthermore, 86% of patients in the Rosa Canina group achieved a successful outcome, compared to 60% in the placebo group (P = 0.003).

Conclusion: The findings suggest that Rosa Canina extract may be an affordable and helpful supplement to standard treatment for reducing serious complications in heart failure patients.
Keywords

Acknowledgements: The authors wish to express their gratitude to the Vice President for Research at Mashhad University of Medical Sciences for the financial support and assistance provided for this study.


Availability of data and material: The data used to support the findings of this study are available from the corresponding author upon reasonable request.


Funding: This study was financially supported by a grant Number 4021952 from Mashhad University of Medical Sciences.


Conflicts of interests: The authors declare that there is no conflict of interest.


Ethical Considerations: This study was approved by the Ethics Committee of Mashhad University of Medical Sciences (Approval No. IR.MUMS.IRH.REC.1403.025) and registered in the Iranian Clinical Trial Registry (IRCT20220516054874N17). All participants provided written informed consent after the study objectives and procedures were fully explained. Data collection was anonymous, and all results were reported in aggregate without patient identifiers. In the event of serious adverse events, immediate medical care was provided, and participants were withdrawn from the study if necessary. All procedures performed in studies involving human participants were by the ethical standards of the institutional research committee and the Declaration of Helsinki of 1964.


Author contributions: M.M: Investigation, Data Curation, Writing Original Draft; V.B.R.: Investigation, formal Analysis, writing the original draft, review and editing the final version of the manuscript; M.T.: Conceptualization, supervision, and investigation; A.H.M.: Conceptualization, investigation; Z.Z.: Methodology, funding acquisition, supervision, investigation, review and editing the final version of the manuscript. M.Y.: Methodology, Supervision, review, and editing of the final version of the manuscript.

Open Access Policy: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/

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